DEVICE: Provicol QM Plus (E22110981)

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Device Identifier (DI) Information

Provicol QM Plus
1098
1098
VOCO GmbH
E22110981
HIBCC
1
Eugenol-free temporary luting cement with calcium hydroxide.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Fatty acid dental cement A non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EMB Zinc Oxide Eugenol
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 4 and 23 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 250 Gram
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Device Status

In Commercial Distribution
October 31, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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